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Daiichi Sankyo Launches Antitumor Agent Trastuzumab Biosimilar for Intravenous Drip Infusions “Daiichi Sankyo” in Japan

On November 28, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it launched the antitumor agent trastuzumab BS for intravenous drip infusions 60 mg and 150 mg "Daiichi Sankyo" (generic name: trastuzumab (genetical recombination)[trastuzumab biosimilar 2], hereafter, "the product") in Japan today (Press release, Daiichi Sankyo, NOV 28, 2018, View Source [SID1234531676]).

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The product is a pharmaceutical agent developed by Amgen Inc. (Headquarters: Thousand Oaks, CA, U.S.A; hereafter, "Amgen") as a biosimilar product to the anti-HER2 antibody, trastuzumab. The product was approved on September 21, 2018, and indicated for breast cancer with HER2 overexpression (Dosage A), and unresectable advanced or relapsed gastric cancer with HER2 overexpression (Dosage B).

Based on the exclusive agreement on the commercialization of biosimilars concluded with Amgen in July 2016, Daiichi Sankyo is responsible for the distribution and commercialization of the product in Japan, while Amgen is responsible for its manufacture.

The product is the first biosimilar product launched by Daiichi Sankyo, and the company expects that the product will provide patients and medical professionals with various options for cancer treatment, thereby further contributing to medical treatment.

Product name

Trastuzumab BS for intravenous drip infusions 60 mg and 150 mg "Daiichi Sankyo"

Generic name

Trastuzumab (Genetical Recombination)[Trastuzumab Biosimilar 2]

Indications

Breast cancer with HER2 overexpression

Unresectable advanced or recurrent gastric cancer with HER2 overexpression

Dosage and administration

・Dosage A is applied for breast cancer with HER2 overexpression.

・Dosage B in combination with other antineoplastic agents is applied for unresectable advanced or recurrent gastric cancer with HER2 overexpression.

Dosage A: In adults 4 mg/kg (body weight) trastuzumab (recombinant) [biosimilar 2 of trastuzumab] is intravenously infused once daily at the first administration, and 2 mg/kg for 90 minutes or longer at one-week intervals for the second and subsequent treatments.

Dosage B: In adults 8 mg/kg (body weight) trastuzumab (recombinant) [generic product 2 of trastuzumab] is intravenously infused once daily at the first administration, and 6 mg/kg for 90 minutes or longer at three-week intervals for the second and subsequent treatments.

If the initial dose is well tolerated, the administration time can be shortened up to 30 minutes for the second and subsequent treatments.

Date of approval for manufacturing and marketing

September 21, 2018

Date of listing in the NHI reimbursement

November 28, 2018

Day of launch

November 28, 2018

Marketing authorization holder

DAIICHI SANKYO COMPANY, LIMITED

Partner

Amgen Inc.

Moleculin Announces New Data Further Supporting Its Lead Drug for Treating Pancreatic Cancer

On November 28, 2018 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that data from an independent test in animal models confirmed, as previously believed, that its immuno-stimulating STAT3 inhibitor achieves disproportionately high accumulation in the pancreas (Press release, Moleculin, NOV 28, 2018, View Source [SID1234531674]).

"Our own sponsored research suggested that WP1732 might be an ideal candidate for treating pancreatic cancer," commented Dr. Donald Picker, Moleculin’s Chief Science Officer. "Now, we have independent testing with radiolabeled drug confirming this in animal models. The propensity for such enhanced pancreatic distribution could be highly beneficial for a new pancreatic cancer drug."

Walter Klemp, Moleculin’s Chairman and CEO added, "Published research shows that the growth and survival of pancreatic cancer requires activated STAT3 (p-STAT3) and our own research suggests that WP1732 may be one of the most effective inhibitors of p-STAT3 that has demonstrated activity in in vivo models. Confirming the disproportionately high accumumulation of WP1732 in the pancreas puts us one step closer to introducing an entirely new approach to treating pancreatic cancer. This is very encouraging and confirms the direction that Moleculin has taken with WP1732. We are heavily engaged in preparing the data necessary for an Investigational New Drug (IND) application with the FDA which we are targeted to file in 2019."

MabVax Therapeutics Holdings, Inc. Announces $1.0 Million Equity Purchase Agreement

On November 28, 2018 MabVax Therapeutics Holdings, Inc. (OTC Pink: MBVX), a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer and pancreatitis, reported that the Company had entered into an equity purchase agreement with Triton Funds LP, a Delaware limited partnership ("Triton Funds"), in which Triton Funds has agreed to purchase up to $1,000,000 of the Company’s to be designated Series P Convertible Preferred Stock, par value of $0.01 per share (the "Series P Preferred Stock"), subject to the effectiveness of an S-1 registration statement that the Company filed with the Securities and Exchange Commission (the "SEC") on November 20, 2018, that registers shares of common stock upon conversion of the Series P Preferred Stock (the "Equity Purchase Agreement") (Press release, MabVax, NOV 28, 2018, View Source [SID1234531673]). Under the terms of the Equity Purchase Agreement, Triton Funds is able to convert the Series P Preferred Stock into common stock at a rate based on the 5-day volume-weighted average price prior to the conversion date, or the stated market purchase price, times 75%. In addition, we agreed to issue 175,000 shares of common stock to Triton Funds LLC, manager of Triton, upon execution of the Equity Purchase Agreement to support the cost of the student-run fund. The summary above is subject to and qualified in its entirety to the Company’s filing of a registration statement on Form S-1 which can be found at:

View Source

Dmitriy Slobodskiy Jr, Research Analyst of Triton Funds, stated, "Here at Triton Funds we strive to locate and invest into companies that make a meaningful impact on significant unmet medical needs. MabVax Therapeutics is one of the cases where a company is developing novel treatments for deadly and debilitating diseases of the pancreas, a small organ that plays a large role in human health."

Sam Yaffa, Founder of Triton Funds, stated, "One of the key factors we look for before we invest is how effective is the management team in advancing the company’s technology, and the team at MabVax has proved to be persistent in its efforts to provide benefits to patients in need of new therapies for unmet medical needs."

President and CEO J. David Hansen, stated, "We are pleased and honored that Triton Funds became interested in MabVax and its clinical stage human antibody development programs for the diagnosis and treatment of pancreatic cancer, and more recently for the development and testing of a clinical stage antibody for the treatment of pancreatitis. We intend to use these proceeds for developing a proof of concept clinical trial protocol for the treatment of pancreatitis using the Company’s antibody designated as MVT-5873 and for general corporate and working capital purposes."

Jazz Pharmaceuticals to Highlight Hematology Research at ASH 2018 Annual Meeting

On November 28, 2018 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that nine abstracts, including two oral presentations, relating to the company’s hematology/oncology portfolio were accepted for the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego from December 1-4 (Press release, Jazz Pharmaceuticals, NOV 28, 2018, View Source;p=RssLanding&cat=news&id=2378498 [SID1234531666]).

"We look forward to showcasing our commitment to the hematology/oncology community at ASH (Free ASH Whitepaper) by advancing the science and addressing the clinical needs of patients with blood cancers and with complications of stem cell transplantation," said Allen Yang, M.D., Ph.D., head of clinical development and acting chief medical officer of Jazz Pharmaceuticals. "We’ve made great progress in the last year with the initiation of new clinical trials for Vyxeos and Defitelio, the marketing authorization of Vyxeos in the European Union, and a collaboration with MD Anderson Cancer Center to evaluate potential treatment options for hematologic malignancies."

Jazz Pharmaceuticals data at the 2018 ASH (Free ASH Whitepaper) Annual Meeting will highlight the following:
Results from a post-hoc analysis from the pivotal Phase 3 randomized trial of Vyxeos (daunorubicin and cytarabine) liposome for injection, also known as the molecule name CPX-351, in a subgroup of older patients with newly diagnosed high risk (secondary) AML with myelodysplasia-related changes (AML-MRC) that evaluated the efficacy of Vyxeos compared to conventional 7+3 chemotherapy on overall survival and remission rates as well as the safety profile in older adults with AML-MRC. Additionally, data will be presented from an exploratory analysis which evaluated the impact of hematopoietic cell transplantation (HCT) on survival in patients treated with Vyxeos compared to 7+3 in the Phase 3 trial.

Vyxeos abstracts include:

Efficacy and Safety of CPX-351 versus 7+3 in a Subgroup of Older Patients with Newly Diagnosed Acute Myeloid Leukemia with Myelodysplasia-Related Changes (AML-MRC) Enrolled in a Phase 3 Study [Abstract #1425; Saturday, December 1, 6:15 PM – 8:15 PM PST]
Population Pharmacokinetic (PK)/Pharmacodynamic (PD) Modeling of Myelosuppression in Patients with Hematologic Malignancies for CPX-351 and Standard-of-Care 7+3 Therapy [Abstract #4037; Monday, December 3, 6:00 PM – 8:00 PM PST]
The Impact of Hematopoietic Cell Transplantation on Survival: An Exploratory Analysis of a Phase 3 Study of CPX-351 versus 7+3 in Older Patients with Newly Diagnosed, High-Risk/Secondary AML [Abstract #2706; Sunday, December 2, 6:00 PM – 8:00 PM PST]
Final Safety and Efficacy Results from the CPX-351 Early Access Program (EAP) for Older Patients with High-Risk/Secondary Acute Myeloid Leukemia (sAML) [Abstract #1434; Saturday, December 1, 6:15 PM – 8:15 PM PST]
Impact of Post–Hematopoietic Cell Transplant (HCT) Survival on Cost-effectiveness of CPX-351 versus 7+3 in the Treatment of Therapy-Related AML or AML-MRC in the United States (online only)
A Phase I/Pilot Study of CPX-351 [Daunorubicin and Cytarabine Liposome for Injection (Vyxeos)] for Children, Adolescents and Young Adults with Recurrent or Refractory Acute Leukemia [Abstract #336; Sunday, December 2, 10:45 AM PST(oral presentation)]
In addition, data from an expanded access program and post-hoc analyses of clinical trials for Defitelio (defibrotide sodium) will be presented, including an oral presentation of a pooled analysis of survival based on timing of initiation in adults with Veno-Occlusive Disease/ Sinusoidal Obstruction Syndrome (VOC/SOS) following hematopoietic stem cell transplant (HSCT).

Defitelio abstracts include:

Incidence of Post-Hematopoietic Stem Cell Transplantation (HSCT) Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome (VOD/SOS) Without Hyperbilirubinemia at Diagnosis and Efficacy of Defibrotide in an Expanded-Access Program [Abstract #2080; Saturday, December 1, 6:15 PM – 8:15 PM PST]
A Pooled Analysis of Survival by Defibrotide Timing of Initiation in Adults with Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome (VOD/SOS) Following Hematopoietic Stem Cell Transplant (HSCT) [Abstract #815; Monday, December 3, 3:45 PM PST (oral presentation)]
Cost-Effectiveness of Defibrotide for the Treatment of Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome (VOD/SOS) with Multi-Organ Dysfunction (MOD) Post-Hematopoietic Stem Cell Transplantation (HSCT) in Canada [Abstract #4702; Monday, December 3, 6:00 PM – 8:00 PM PST]
About Vyxeos
Vyxeos (daunorubicin and cytarabine) is a liposome formulation of a fixed combination of daunorubicin and cytarabine for intravenous infusion, and is approved for the treatment of two types of secondary AML in adult patients, newly diagnosed therapy-related acute myeloid leukaemia (t-AML) and AML with myelodysplasia-related changes (AML-MRC). Vyxeos is the first product developed with the company’s proprietary CombiPlex platform, which enables the design and rapid evaluation of various combinations of therapies. Vyxeos received U.S. FDA approval and orphan drug exclusivity in August 2017 and EU EMA marketing authorization in August 2018. Vyxeos received Orphan Drug Designation for the treatment of AML by the U.S. FDA in September 2008 and by the European Commission in January 2012 (with retention of the designation reaffirmed in July 2018). Vyxeos received Promising Innovative Medicine (PIM) designation from the Medicines and Healthcare Products Regulatory Agency in the United Kingdom.

Important Safety Information
Vyxeos has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute Vyxeos for other daunorubicin- and/or cytarabine- containing products.

Vyxeos should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine or any of its ingredients.

Vyxeos can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with Vyxeos. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding.

Vyxeos can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as:

shortness of breath or trouble breathing
swelling or fluid retention, especially in the feet, ankles or legs
unusual tiredness
Vyxeos may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:
trouble breathing
severe itching
skin rash or hives
swelling of the face, lips, mouth, or tongue
Vyxeos contains copper and may cause copper overload in patients with Wilson’s disease or other copper-processing disorders.

Vyxeos can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site.

Vyxeos can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Do not breastfeed while receiving Vyxeos. Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of Vyxeos.

The most common side effects were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting.

Please see full Prescribing Information for Vyxeos including BOXED Warning, and visit www.Vyxeos.com for additional information.

About Defitelio
In the U.S., Defitelio (defibrotide sodium) injection 80mg/mL received U.S. FDA marketing approval on March 30, 2016 for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT) and is the first and only FDA-approved therapy for patients with this rare, potentially fatal complication.

In Europe, defibrotide is marketed under the name Defitelio* (defibrotide). In October 2013, the European Commission granted marketing authorization to Defitelio under exceptional circumstances for the treatment of severe VOD in patients undergoing HSCT therapy. It is the first and only approved treatment in Europe for severe VOD. In Europe, Defitelio is indicated in patients over one month of age. It is not indicated in patients with hypersensitivity to defibrotide or any of its excipients or with concomitant use of thrombolytic therapy.

*This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system found under section 4.8 of the SmPC. (View Source)

Important Safety Information

Defitelio should not be given to patients who are:

Currently taking anticoagulants or fibrinolytics
Allergic to Defitelio or any of its ingredients
Defitelio may increase the risk of bleeding in patients with VOD and should not be given to patients with active bleeding. During treatment with Defitelio, patients should be monitored for signs of bleeding. In the event that bleeding occurs during treatment with Defitelio, treatment should be temporarily or permanently stopped. Patients should tell the doctor right away about any signs or symptoms of hemorrhage such as unusual bleeding, easy bruising, blood in urine or stool, headache, confusion, slurred speech, or altered vision.

Defitelio may cause allergic reactions including anaphylaxis. Patients who develop signs and symptoms of anaphylaxis such as trouble breathing, severe itching, skin rash or hives, or swelling of the face, lips, mouth or tongue should seek medical attention immediately.

The most common side effects of Defitelio are decreased blood pressure, diarrhea, vomiting, nausea and nose bleeds.

Please see full Prescribing Information for Defitelio and visit www.Defitelio.com for additional information.

Kura Oncology Announces New Patent for Tipifarnib in Angioimmunoblastic T-Cell Lymphoma

On November 28, 2018 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that the U.S. Patent and Trademark Office (USPTO) has issued a new patent protecting the Company’s lead drug candidate, tipifarnib, a potent and selective farnesyl transferase that is currently being studied in multiple solid tumor and hematologic indications, including a registration-directed trial in HRAS mutant head and neck squamous cell carcinoma (HNSCC) and a Phase 2 trial in peripheral T-cell lymphoma (PTCL) (Press release, Kura Oncology, NOV 28, 2018, View Source [SID1234531664]).

U.S. Patent No. 10,137,121, "Methods of Treating Cancer with Farnesyltransferase Inhibitors," includes multiple claims directed to the use of tipifarnib as a method of treating patients with angioimmunoblastic T-cell lymphoma (AITL), an aggressive form of T-cell lymphoma. The newly issued patent has an expiration date of November 2037, excluding any possible patent term extension. Kura continues to pursue U.S. and foreign patent protection in this and other indications.

"The issuance of this new patent is an important achievement for Kura and reflects our ability to expand the breadth and depth of tipifarnib’s development opportunities," said Troy Wilson, Ph.D., President and CEO of Kura Oncology. "This patent comes just six months after the USPTO issued us a patent for the use of tipifarnib as method of treating patients with certain CXCL12-expressing cancers, further strengthening our intellectual property protection for tipifarnib based on genetically defined patient populations and disease indications."

Kura is evaluating, on a prospective basis, the role of the CXCL12 pathway and markers of bone marrow homing as potential biomarkers of clinical activity for tipifarnib in hematologic malignancies. The Company’s ongoing Phase 2 trial of tipifarnib in PTCL is enrolling patients into two expansion cohorts. The first cohort is defined by histology and includes patients with AITL. The second cohort is defined by genetics and includes patients with PTCL not otherwise specified (NOS) who have the absence of a single nucleotide variation in the 3’ untranslated region of the CXCL12 gene. The Company estimates that the combined addressable populations of patients with AITL and CXCL12+ account for approximately 40% of all PTCL cases.

Kura plans to report preliminary data from both expansion cohorts in its Phase 2 trial of tipifarnib at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego on Sunday, December 2, 2018. A copy of the poster will be available on the Company’s website at www.kuraoncology.com following presentation at the meeting.

About Tipifarnib

Kura Oncology’s lead candidate, tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. Tipifarnib was previously studied in more than 5,000 cancer patients and showed compelling and durable anti-cancer activity in certain patient subsets with a manageable side effect profile. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics and tumor biology, the Company is seeking to identify those patients most likely to benefit from tipifarnib. Based on positive results from a Phase 2 clinical trial in HRAS mutant HNSCC and feedback from the U.S. Food and Drug Administration, Kura recently initiated a global, registration-directed trial of tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC.